BEUDAMED
    FDA Adverse Event Other Summary report: N

    HU-FRIENDLY SAS13/1498

    MDR report key: 3453066 · Received October 8, 2013

    Report

    Report Number
    1416605-2013-00005
    Event Type
    Other
    Date Received
    October 8, 2013
    Date of Event
    July 1, 2013
    Report Date
    October 8, 2013
    Manufacturer
    HU-FRIEDY MFG. CO., LLC
    Product Code
    EKE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRACTICE RETURNED THE BROKEN DEVICE TO HU-FRIEDY ON (B)(4) 2013. THE RETURNED DEVICE WAS REVIEWED AND IT WAS DETERMINED ON (B)(4) 2013 THAT THIS WAS A NON-REPORTABLE INCIDENT. HOWEVER, ON (B)(4) 2013, HU-FRIEDY WAS NOTIFIED BY (B)(4)) THAT THE PRACTICE REPORTED THE BREAKAGE. THEREFORE, HU- FRIEDY IS SUBMITTING THIS REPORT ON (B)(4) 2013. RETURNED INSTRUMENT HAS BEEN OVER-SHARPENED BY THE END USER. THE ORIGINAL SHAPE OF THE WORKING END HAS BEEN ALTERED AND THE CUTTING EDGE IS EXCESSIVELY DULL. ADDITIONALLY, THIS TYPE OF INSTRUMENT (SCALERS) HAS A NORMAL LIFE EXPECTANCY OF 9-12 MONTHS. THE RETURNED INSTRUMENT WAS MANUFACTURED JUNE 2010. SECTION A- WEIGHT AND AGE OF PATIENT IS NOT KNOWN, OFFICE WAS NOT ABLE TO PROVIDE INFORMATION. SECTION D- HU-FRIEDY DOES NOT TRACK OUR DEVICES, WHICH ARE MOSTLY LOW RISK CLASS 1 DEVICES, BY SERIAL NUMBER, ONLY A LOT NUMBER WHICH IS TIED TO THE DATE OF MANUFACTURE. THE PRODUCT INVOLVED IN THE EVENT WAS A STAINLESS STEEL INSTRUMENT THAT DOES NOT HAVE A EXPIRATION DATE. THE DEVICE IS NOT IMPLANTED, THEREFORE, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. SECTION G- #5: ALL ARE NOT APPLICABLE. THIS IS A CLASS 1 EXEMPT DEVICE.

    Description of Event or Problem · 1

    DURING A DENTAL PROCEDURE ON (B)(6) 2013, THE TIP OF THE DEVICE BROKE IN THE PATIENT'S MOUTH. THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION REQUIRED. THE TIP WAS RETRIEVED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508993 HU-FRIENDLY SAS13/1498 13/14 MINI 5 GRACEY EVEREDGE #9 HDL, BLUE EKE HU-FRIEDY MFG. CO., LLC SAS13/1498 0610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA NO CONCOMITANT MEDICAL PRODUCTS & THERAPY DATES,| REPORTED.